Z-1035-2012

TSX-301B: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial Number: 2005, 2008, 2010...

Name: Z-1035-2012 TSX-301B: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial Number: 2005, 2008, 2010...
Creator: Toshiba American Medical Systems Inc
Published: 2012-01-03
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2012-01-03 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of TSX-301B: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial Number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052... on 2012-01-03. The reason FDA records is "The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1035-2012
Status: Terminated
Initiated: 2012-01-03
Posted: 2012-02-15
Terminated: 2013-04-08
Recalling firm: Canon Medical Systems USA, Inc.
Product: TSX-301B: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial Number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2123, 2131, 2133, 2139, 2143, 2148, 2151, 2158, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2174, 2208, 2211, 2212, 2219, 2220, 2222, 2241, 2253, 2257, 2265, 2275, 2283, 2284, 2291, 2294, 2308, 2311, 2316, 2324, 2328, 2332, 2333, 2006, 2007, 2008, 2011, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2025, 2027, 2030, 2031, 2032, 2033, 2035, 2002, 2004. Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition, the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE, Toshiba's top of the line X-ray CT system, is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba sent an Urgent Medical Device Correction letter to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax the attached form to (877) 349-3054. The form can also be sent via email to [email protected]. Customers with any questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 82 units total
Distribution: Nationwide Distribution - USA (nationwide) and Puerto Rico
Product codes and lots: Lot number is not utilized

Product code JAK

K083282Class IIModel Tsx-301B Aquilion CT SystemToshiba America Medical Systems, In.C / cleared 2008-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)